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Recruiting NCT06499701

Volume Kinetics of Fluid Resuscitation in Early Sepsis

Trial Parameters

Condition Fluid and Electrolyte Imbalance
Sponsor Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Study Type OBSERVATIONAL
Phase N/A
Enrollment 15
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-19
Completion 2026-07-01
Interventions
Ringer's Lactate

Brief Summary

The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml/kg of crystalloid administered within the first three hours. However, this standardized approach does not account for individual patient variability and lacks personalization. Additionally, the effects of administering 30 ml/kg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear. This study aims to describe the volume kinetics of administering 30 ml/kg of Ringer's Lactate in patients with early sepsis-induced hypoperfusion within the first three hours.

Eligibility Criteria

Inclusion Criteria: A diagnosis of sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation: * hypotension requiring norepinephrine to maintain a mean arterial blood pressure (MAP) either predefined by the clinician or at 65 mm Hg or higher and/or * a serum lactate level \>2 mmol/L (18mg/dL) and/or * acute oliguria defined as urine output \<0.5mL/kg/hr and/or * mottled skin and/or * capillary refill time \> 3 seconds. Exclusion Criteria: * Administration of at least 1 L of IV fluid in the last 6 hours prior to screening. All crystalloids, colloids and blood products that the patient has received are counted. * Known pregnancy. * Competing causes of lactic acidosis including: seizures within 3 hours of enrollment, use of linezolid or metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial diso

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